WO2024110558A1

WO2024110558A1 - Adapter for filling and subsequent closing of a pharmaceutical composition container, and container with adapter

Info

Publication number: WO2024110558A1
Application number: PCT/EP2023/082757
Authority: WO
Inventors: Christoph EGLOFF; Urs Jann; Lukas Bannwart
Original assignee: Shl Medical Ag
Priority date: 2022-11-22
Filing date: 2023-11-22
Publication date: 2024-05-30

Abstract

The invention provides an adapter for filing and subsequent closing of a pharmaceutical composition container, the adapter comprising a housing having a first axis, the housing having a cavity with an opening coupleable to a port of the container; a closure element arranged in the cavity and displaceable from a first position to a second position, in a direction along the first axis; a push rod being at least partially arranged outside the cavity and being movable by a user in a direction along the first axis for displacing the closure element; the housing having an entry port with an entry port opening in communication with the cavity, at least part of the entry port opening being located axially between the first position of the closure element and the opening when viewed along the first axis.

Description

Adapter for filling and subsequent closing of a pharmaceutical composition container, and container with adapter

Technical Field

The present disclosure relates to the filling of a drug container. The disclosure is particularly, but not exclusively, applicable to an adapter for filling and subsequently closing a pharmaceutical composition container, such as a flat medicament bag made of plastics.

Background

An exemplary drug container is a flat medicament bag made of one or more plastics showing excellent barrier properties that may allow long storage like glass vials. Such an exemplary drug container may contain three main parts: a film of one or more layers, which is welded to form a bag; a port, which contains interfaces and provides access to the interior of the bag; and a closure to close the port.

US 8 763 798 B2 relates to a closure for filling and sealing receptacles containing medicinal fluids, a method for filling a receptacle with a medicinal fluid and sealing the receptacle. The closure used in the method comprises a mounting piece that may be attached to the receptacle and a connector piece that may be connected to a connector piece of a filling device. A closure body is arranged between the mounting piece and the connector piece, in which a closure piece for sealing the closure sits. The closure piece may be slid between a position sealing the closure and a position which opens the closure. The closure is sealed tight with a removable protective cap. The receptacle is filled through the closure in a clean room. After filling, the closure is sealed by pressing the closure piece into the closure.

Such drug containers have generally been developed to be filled in industrial environment on an automated filling station in aseptic environment, in order to minimize the risk of contamination. However, this can be inconvenient and involve undesirable logistics.

Summary of the Disclosure An object of the invention is to provide a filling tool that allows for the filling of a drug container and to provide a medicament bag designed for being filled in either an industrial environment or in a clinical setting, such as a treatment room or pharmacy, by a medical practitioner, nurse or pharmacist. This object is achieved with an adapter according to independent claim 1, a container with an adapter according to independent claim 11 or 12, or a combination according to claim 15. Preferred embodiments are defined in the dependent claims.

According to a first aspect of the present disclosure, there is provided an adapter for filling and subsequent closing of a pharmaceutical composition container, the adapter comprising: a housing having a first axis, the housing having a cavity with a cavity opening coupleable to a port of the container; a closure element arranged in the cavity and displaceable from a first position to a second position, in a direction along the first axis; a push rod being arranged at least partially outside the cavity and being movable by a user in a direction along the first axis for displacing the closure element; the housing having an entry port with an entry port opening in communication with the cavity, at least part of the entry port opening being located axially between the first position of the closure element and the cavity opening when viewed along the first axis.

According to a preferred aspect, the entry port has an entry port channel, at least part of the length of which is perpendicular to or is inclined with respect to the first axis.

According to a preferred aspect, the adaptor has two opposing sides along the first axis, one side being the side where the adapter is connectable to a port of the container, the other, second side for being held and/or operated by a user.

According to a preferred aspect, the push rod has a generally T-shape in cross-section along the first axis.

According to a preferred aspect, the adapter further comprises a pierceable septum in the entry port channel. According to a preferred aspect, the entry port comprises one or more of a self-sealing elastomeric septum, needleless connector, female Luer connection, male Luer connection, Luer access valve, Luer activated device, or combinations thereof, at the end opposite to the cavity opening.

According to a preferred aspect, the entry port is configured to cooperate with at least one or more of a male Luer connector, female Luer connector, vial adapter, vial spike, IV tubing set spike, or combinations thereof.

According to a preferred aspect, the entry port is configured to cooperate with at least one closed-system transfer device or component.

According to a preferred aspect, the closure element is adapted to seal the port of the container.

According to a preferred aspect, the closure element is configured to remove substantially all of a drug from the cavity.

According to a preferred aspect, the closure element is configured to remove substantially all of a drug from the cavity after filling and displacement of the closure element.

According to a preferred aspect, the closure element is adapted to enter into a connection with the port of the container and to be released from the adapter upon removal of the adapter from the container.

According to a preferred aspect, the closure element is a plunger for expelling fluid from the cavity.

According to a preferred aspect, the closure element is a substantially elastomeric material. According to a preferred aspect, the closure element is a blend of thermoplastic elastomer and an olefin polymer.

According to a preferred aspect, the cavity is made from an olefin polymer.

According to a preferred aspect, the adapter is configured such that one or more portions of the adapter or the housing are removed from the container after filling.

According to a preferred aspect, the adapter is configured such that one or more portions of the adapter or the housing are removed from the container after filling and displacement of the closure element.

According to a preferred aspect, the adapter housing has a protruding structure for being gripped by a user during use. The adapter housing may be generally elongate along the direction of the first axis, preferably generally cylindrical.

According to a preferred aspect, the push rod protrudes along the first axis from the adapter housing (510) at the side for being held and/or operated by a user.

According to a preferred aspect, the push rod protrudes along the first axis from the adapter housing at the side for being held and/or operated by a user.

According to a preferred aspect, the adapter housing has one or more connecting elements for connecting the adapter housing with the container housing. The one or more connecting elements may provide a releasable connection between the adapter housing with the container housing. The releasable connection may be a snap connection or a screw connection.

According to a preferred aspect, the adapter housing has a second axis perpendicular to the first axis, and wherein the adapter housing has two opposite connecting elements for connecting the adapter housing with the container housing, opposite along the second axis. The connecting elements may be flexible elements providing a releasable connection to the container housing. Each flexible element may be at its one end integral with the adapter housing and the opposite flexible end comprising a locking feature.

According to a preferred aspect, the locking feature is a ledge extending in a direction perpendicular to the plane defined by first axis and second axis and projecting along second axis, or the locking feature is a groove extending in a direction perpendicular to the plane defined by first axis and the second axis and being recessed along second axis.

According to a preferred aspect, the push rod is embedded in the adapter housing such that the outermost end surface is flush with a surface of the adapter housing. The adapter housing may have a stepped structure so that the push rod is displaceable towards the container. The stepped structure may be generally a U-shaped structure.

According to a preferred aspect, the entry port comprises a valve element for connecting the entry port with a syringe. The syringe may be a needleless syringe.

According to another aspect of the present disclosure, there is provided a container for a pharmaceutical composition having a separable and removable adapter for filling and subsequent closing of the container, the adapter as defined in any one of the preceding aspects, the container further comprising a medicament bag, and a port configured for being removably connected with the adapter.

According to a preferred aspect, the medicament bag is a flexible medicament bag, preferably a flat flexible bag.

According to a preferred aspect, the container further comprises a container housing accommodating the medicament bag. The port may be part of the medicament bag or part of the container housing.

According to a preferred aspect, the container housing comprises one or more container connecting elements mating with the adapter connecting elements. Each container connecting element may comprises a locking feature. The locking feature may be a corresponding groove or ledge.

According to another aspect of the present disclosure, there is provided a container for a flexible bag having an inner space to accommodate a volume of liquid, the container comprising: a container housing for accommodating the flexible bag; an outlet port for communication of the inner space of the flexible bag with the exterior of the container; and one or more container connecting elements mating with connecting elements of a flexible bag filling adapter.

According to a preferred aspect, each container connecting element comprises a locking feature.

According to a preferred aspect, the container housing has a container housing case and a container housing lid.

According to a preferred aspect, the one or more container locking feature comprise a case locking feature and a lid locking feature.

According to a preferred aspect, the container connecting element is formed as a recess in the circumferential walls of the container housing case and the container housing lid. The locking feature may be formed as a ridge at the wall of the recess.

According to a preferred aspect, the container further comprises an adapter for filling and subsequent closing of the flexible bag in the container.

According to a preferred aspect, the adapter comprises: a housing having a cavity with a cavity opening coupleable to a port of the container; a closure element arranged in the cavity; a push rod being arranged at least partially outside the cavity and being movable by a user; the housing having an entry port with an entry port opening in communication with the cavity.

According to a further aspect of the present disclosure, there is provided a combination of an adapter for filling and subsequent closing of a pharmaceutical composition container and a container frame, the adapter comprising: a housing having a first axis, the housing having a cavity with a cavity opening; a closure element arranged in the cavity and displaceable from a first position to a second position, in a direction along the first axis; a push rod being arranged at least partially outside the cavity and being movable by a user in a direction along the first axis for displacing the closure element; the housing having an entry port with an entry port opening in communication with the cavity, at least part of the entry port opening being located axially between the first position of the closure element and the cavity opening when viewed along the first axis; wherein the adapter housing has one or more connecting elements for connecting the adapter housing with the container frame.

According to a preferred aspect, the one or more connecting elements provide a releasable connection between the adapter housing with the container frame.

According to a preferred aspect, the releasable connection is a snap connection or a screw connection.

One advantage of the invention is that it allows for filling the drug container in multiple scenarios, e.g. in an industrial environment or in a clinical setting.

Brief Description of Drawings

The invention will be described with reference to the drawings in which:

Fig. 1 is a perspective view of a container with an adapter according to a first embodiment of the present invention. Fig. 2 is a front view of the container with an adapter of Fig. 1 according to the first embodiment of the present invention.

Fig. 3 shows the medicament bag of the container in communication with the adapter according the first embodiment of the present invention.

Fig. 4 shows the medicament bag of the container decoupled from the adapter according the first embodiment of the present invention.

Fig. 5 shows the adapter according to the first embodiment of the present invention.

Fig. 6 shows an exploded perspective view of the adapter according to the first embodiment of the present invention.

Fig. 7 shows a perspective bottom view of the housing of the adapter according to the first embodiment of the present invention.

Fig. 8 shows a different exploded perspective view of the adapter according to the first embodiment of the present invention.

Fig. 9 shows a perspective top view of the housing of the adapter according to the first embodiment of the present invention.

Fig.10 shows a perspective cross-sectional view of the housing of the adapter according to the first embodiment of the present invention.

Fig. 11 shows a perspective view of a different cross-section of the housing of the adapter according to the first embodiment of the present invention.

Fig. 12 shows a cross-section of an adapter according to a second embodiment of the present invention.

Fig. 13 illustrates the use of the adapter of the second embodiment of the present invention.

Fig. 14 illustrates further steps of the use of the adapter of the second embodiment of the present invention.

Fig. 15 illustrates details of the container according to an embodiment of the present invention.

Fig. 16 illustrates an exploded perspective view of the container of Fig. 15.

Fig. 17 illustrates a perspective inner view of the container housing case.

Description of Embodiments Fig. 1 is a perspective view of a container 300 with an adapter 100 according to a first embodiment of the present invention. Fig. 1 shows the adapter 100 releasably coupled to the container 300. The adapter 100 has an entry port and a syringe 400 is shown releasably connected to the adapter 100 at the entry port. The container 300 has a container housing 320, and a medicament bag (not shown) is in the container housing 320. The medicament bag in the container 300 can be filled from the syringe 400 via the adapter 100.

Fig. 1 also shows the push rod 140 of the adapter 100 and the connecting elements releasably connecting the adapter 100 to the housing 320 of the container 300. In Fig. 1, the container connecting element 340 is seen. This will be described in more detail below. It can also be seen that in this embodiment the top surface of the push rod 140 is flush with the top surface of the adapter housing 110. However, the flush configuration is optional, the top surface of the push rod 140 can also protrude from the top surface of the adapter housing 100 or be recessed in relation thereto. The function of the push rod 140 will be described in more detail below.

Fig. 1 also illustrates the second aspect of the invention. The second aspect is a ccontainer 300 for a pharmaceutical composition having a separable and removable adapter 100 for filling and subsequent closing of the container 300, both being pre-assembled. Thus, according to this aspect of the invention the container 300 and the adapter 100 are provided preassembled as a kit set. The syringe 400 containing the pharmaceutical composition with which the medicament bag is to be filled is provided separately and is connected by the user to the adapter 100 of the pre-assembled kit. After the pharmaceutical composition has been filled into the medicament bag and the medicament bag has been closed, the syringe 400 is removed from the adapter 100, and the adapter 100 is decoupled or released from the container 300. Alternatively, the adapter 100 with the syringe 400 still being connected to it is removed from the container 300.

Fig. 2 is a front view of an adapter 100 of Fig. 1 with the container 300 of Fig. 1 according to the first embodiment of the present invention. The front view of the adapter 100 is defined as the view showing the entry port 150 (see Fig. 4). Fig. 2 also shows that the top surface or outermost end surface 141 of the push rod 140 is flush with the top surface 111 of the adapter housing 110. The adapter housing 110 has a first axis A and a second axis B perpendicular to the first axis. In the view of Fig.2, the first axis is the vertical axis, and the second axis is a horizontal axis from left to right. Reference will be made to these axes below.

The adapter housing 110 has a connecting element 160 for releasably securing the adapter housing 110 to the container housing 320. In the illustrated embodiment, there are two connecting elements 160, opposed to one another, e.g. in the sense that they are operable in opposing directions - in the illustrated embodiment by being pressed towards one another. Preferably, in case two connecting element 160 are provided, they are arranged in symmetry with respect to the entry port into the medicament bag. Such symmetrical arrangement allows for a simple coupling of the adapter 100 of the container 300 because the user does not have to care about correct orientation of the adapter 100 with respect to the container 300.

In the illustrated embodiment, the adapter housing 110 has a generally rectangular cross section in the vertical plane (e.g., the plane of the drawing of Fig. 2 defined by axes A and B). It may also have a generally rectangular cross-section in the horizontal plane (i.e., the plane to which axis A is perpendicular). The two connecting elements 160 are provided at the opposite smaller sides of the adapter housing 110. In this illustrated example, the container 300 also has a generally rectangular cross section in the horizonal and vertical planes. However, alternative shapes are also encompassed by the present invention. For example, a square cross-section of the adapter 100 and/or the container 300 in horizontal and or vertical planes(s) is also envisaged. As a further example, the container 300 has an elliptical, semicircular, or even circular cross section in the horizontal plane. The cross section of the adapter 100 might be adapted to such cross section of the container 300, and so the adapter 100 in an alternative embodiment has a circular cross section in the horizontal plane. In such an alternative embodiment, three connecting elements 160 may be provided, spaced from each other by 120° around the vertical center axis, and operable by a user with three fingers.

Each connecting element 160 has a locking feature 161 that connects to a mating locking feature 341 of the container connecting element 340, although other arrangements are possible. The connecting elements 160 a re flexible elements providing a releasable connection to the container housing 320. In the illustrated embodiment, each flexible element is at its one end integral with the adapter housing 110 and the opposite flexible end comprises the locking feature 161. The locking feature 161 is a ledge extending in a direction perpendicular to the plane defined by axis A and B and projecting along axis B. Alternatively, the locking feature is a groove extending in a direction perpendicular to the plane defined by axis A and B and being recessed along axis B. The locking feature 341 of the container 300 is a corresponding, mating groove or ledge.

Such mating locking features 161, 341 provide a releasable securing of the adapter 100 to the container 300 along the first axis A. Alternatively, the locking features 161, 341 are shaped such that a sliding movement along the axis of the entry port 150 (i.e., perpendicular to axis A) is required to couple the adapter 100 to the container 300. As a further alternative, the connecting elements 160, 340 have a curved shape (curved around the first axis) or helical shape so that the adapter 10 is connected to the container 300 with a rotational movement over some degrees of rotation, bringing the connecting elements 160, 340 slidingly into engagement. With such a configuration the connecting elements 160 of the adapter 100 need not be flexible but can be formed as protrusions of the adapter housing 110.

Fig. 3 shows the medicament bag of the container 300 in fluid communication with the adapter 100 according the first embodiment of the present invention. In this drawing, the container housing 320 is removed so that the medicament bag 310 can be seen.

Fig. 4 shows the medicament bag 310 of the container released from the adapter 100 according the first embodiment of the present invention. In this drawing, the container housing 320 is also not shown, and the adapter 100 is shown in a disconnected state, for example prior to connecting it to the container 300 before filling the medicament bag 310, or after the filling has been completed. The medicament bag 310 has a port 330 to which the adapter 100 is couplable at a corresponding coupling element. In Fig. 3 and in Fig. 4 the push rod 140 is shown in its first, for example, initial position where the outer surface 141 is flush with the outer surface 111 of the adapter housing 110.

Fig. 5 shows the adapter 100 according to the first embodiment of the present invention. In this drawing, the adapter 100 is shown in a state where the push rod 140 has already been operated by a user. The push rod 140 has been displaced along the first axis towards the medicament bag (not shown). This displacement requires a stepped structure of the adapter housing 110, which will be clearer below.

Fig. 6 shows an exploded perspective view of the adapter 100 according to the first embodiment of the present invention. Fig. 6 shows the adapter housing 110 with the adapter connecting elements 160 with its ledges 161 and the entry port 150. Fig. 6 also shows part of a cavity 120 of the adapter housing 110, which cavity 120 is open towards a cavity opening 121 for fluid communication with the medicament bag 310. Fig. 6 also shows the push rod 140 in more detail. The push rod 140 is at least partially arranged outside the cavity 120 and is movable by a user in a direction along the first axis A for displacing the closure element 130 within the cavity 120. The wording "at least partially arranged outside the cavity" refers to a state shown in Fig. 1, for example, where the push rod 140 is in its initial position. Upon moving it towards the medicament bag to reach a state as shown in Fig. 5, the push rod 140 is moved into the cavity 120 to displace the closure element 130. Fig. 6 further shows O-rings 144, 145, and gasket 146. The O-rings 144, 145 are located on push rod 140 and cooperate with an inner surface of the cavity 120 to provide a fluid tight seal. This helps to ensure that the pharmaceutical composition is expelled from the cavity 120 as the medicament container 300 is closed. The gasket 146 is located between the adapter 100 and the container 300 and helps to ensure a fluid tight seal between the adapter 100 and the port 330 of the container 300.

In cross-section, the push rod 140 of this exemplary embodiment has generally a T-shape. The vertical part of the T being formed by a generally cylindrical part, and the horizontal part being formed by a flat plate forming the outer surface 141. In addition, the push rod 140 may have opposing side elements 142 extending parallel to the central vertical part or stem so that the space formed by the push rod 140 is closed and guided by the adapter housing 110. As shown in Fig. 6, one side element may have a recess 143 the shape of which is mating with the shape of the entry port 150 so that upon movement of the push rod 140 there is no conflict with the entry port 150.

Fig. 6 also shows the stepped structure of the adapter housing 110. The stepped structure is generally a U-shaped structure. The stepped structure allows for a displacement of the push rod 140 from an initially flush position (as sown in Fig. 1) to the position shown in Fig. 5. However, as described above, the flush configuration is a design option, and the push rod 140 can likewise protrude upwards from the surface 111 of the adapter housing 110. With such configuration, no stepped structure of the adapter housing 110 is necessary, i.e., the upper surface 111 of the adapter housing is contiguous.

Furthermore, Fig. 6 shows a valve element 170, for example, a swabable valve, for attaching or connecting or coupling a syringe, for example a needle-free syringe.

Fig. 7 shows a perspective bottom view of the housing 110 of the adapter 100 according to the first embodiment of the present invention. In the bottom view of Fig. 7, the cavity 120 and its arrangement relative to the entry port 150 is clearly seen.

Fig. 8 shows a different exploded perspective view of the adapter 100 according to the first embodiment of the present invention. In this drawing, the entry port opening 151 is seen. At the entry port opening 151, the entry port 150 is in fluidic communication with the cavity 120 of the adapter housing 110.

Fig. 9 shows a perspective top view of the housing of the adapter 100 according to the first embodiment of the present invention. Again, the cylindrical cavity 120 is illustrated in this drawing, and the entry port 150.

Fig. 10 shows a perspective cross-sectional view of the housing 110 of the adapter 100 according to the first embodiment of the present invention. The cross section is drawn in the plane formed by the first axis A and a third axis being perpendicular to the first axis A and the second axis B. This cross-sectional view shows the entry port 150 with its entry port channel 152 and the entry port opening 151. In this embodiment, the axis of the entry port channel 152 is perpendicular to the axis of the cavity 120.

The opening 151 enters into the cavity 120 at a location along first axis A that is between the closure element 130 in its first, for example initial, position, and the cavity opening 121. In other words, the opening 151 is located axially between the first position of the closure element 130 and the cavity opening 121 when viewed along the first axis A. The axial position of the opening 151 is preferably such that the closure element 130 when being in its initial position does not overlap with the opening 151, and that the closure element 130 in its final position does also not overlap with the opening 151. However, partial overlap in one or both of these positions of the closure element 130 with the opening 151 is encompassed by the present disclosure.

The cavity 120 has a portion of slightly larger diameter towards the cavity opening 121. This facilitates mating with the port 330 of the medicament bag 310. The cavity 120 also has a portion of slightly larger diameter towards the other end, e.g. the end opposite to that of the cavity opening 121, and on a side of the entry port 150 that is away from the cavity opening. This helps to keep the closure element 130 in place before using the adapter 100.

Fig. 11 shows a perspective view of a different cross-section of the housing of the adapter according to the first embodiment of the present invention. This cross section is drawn in a plane formed by the first axis A and the second axis B. The opening 151 connecting the entry port channel 152 with the cavity is seen, and also the cavity opening 121.

Fig. 12 shows a cross-section of an adapter 500 according to a second embodiment of the present invention. In this embodiment, the adapter 500 has a different configuration.

The adapter 500 of this embodiment has a housing 510 that is generally elongate, and in this preferred embodiment at least is generally cylindrical in shape. The housing 510 defines a cavity 520 that has a cavity opening 521 at the end facing the medicament bag 310 or the medicament container 300, respectively, when the adapter 500 is in use. At the cavity opening 521 the housing 510 has a structure for mounting the adapter 500 to the container 300. In Fig. 12, the adapter 500 is shown coupled to the port 330 of the medicament bag 310 in the container 300. A closure element 530 is located in the cavity 520. A push rod 540, which may be T-shaped in cross section, is shown at least partially arranged outside the cavity 520 (and at least partially within the cavity 520) and is movable by a user in a direction along the first axis A for displacing the closure element 530 within the cavity 520. The housing 510 has wings 560 for being gripped by a user during use of the adapter 500. The housing 510 has an entry port 550 with an entry port opening 551 and an entry port channel 552. In the illustrated embodiment, the entry port channel 552 is closed with a septum 555.

The entry port channel 552 is shown inclined with regard to the first axis A. For example, at least part of the length of entry port channel 552 is inclined with respect to the first axis A (or the second axis B). Thus, the axis of at least part of the length of entry port channel 552 lies in the plane defined by axes A and B. In an alternative embodiment, the the axis of at least part of the length of entry port channel 552 may further be inclined with regard to the plane defined by axes A and B. However, the entry port channel 552 may also be oriented perpendicular to the first axis A, like it is shown in the first embodiment, i.e., along the second axis B. In a further alternative embodiment, the entry port channel 552 may be oriented perpendicular to the first axis A and also inclined with respect to the plane defined by axes A and B.

The opening 551 enters into the cavity 520 at a location along first axis A that is between the closure element 530 in its first, for example initial, position, and the cavity opening 521 . In other words, the opening 551 is located axially between the first position of the closure element 530 and the cavity opening 521 when viewed along the first axis A. The axial position of the opening 551 is preferably such that the closure element 530 when being in its initial position does not overlap with the opening 551, and that the closure element 530 in its final position does also not overlap with the opening 551. However, partial overlap in one or both of these positions of the closure element 530 with the opening 551 is encompassed by the present disclosure.

As shown in Fig. 12, after the main drug container production, the container 300 is (pre- )assembled with the adapter 500 for the pharmacy or clinic filling scenario. This assembly can be packed as a single piece. The adapter 500 contains the closure 530 which is needed to close the system. The design of adapter 500 is like a syringe, but instead of a plunger in a syringe the closure element 530 in the adapter 500 is moved by the push rod 540 inside the cavity 520. A connection to the adapter cavity 520 by the entry port 550 allows the filling of the drug container 300.

Fig.12 shows a septum 555 which can be pierced with a cannula multiple time. The septum 555 is arranged in the entry port channel 552 as a closure of the entry port 550 at the end opposite to the entry port opening 551. Alternatively, it is also possible to have a Luer connection or both, other non-Luer connections, or other suitable connectors. For example, a cooperating connection may be provided for a closed-system transfer device (CSTD) or components thereof to avoid user exposure to a medication filled into the drug container using the apparatus.

Fig. 13 illustrates the use of the adapter 500 of the second embodiment of the present invention. The left-hand figure shows the (pre-)assembled adapter 500 and drug container 300. The next stage of use is shown in the right-hand figure. It illustrates how the septum 555 is pierced by the filling syringe, and the medicament is transferred via the cavity 520 and through the cavity opening 521 into the medicament container 300 (medicament flow highlighted by the two arrows). Once the medicament container 300 is filled, the syringe is is removed, as by withdrawal, unscrewing, etc. If needed, one or more further components can be inserted this way into the container 300. Thus, this process may be repeated any number of times if necessary. For instance, if a 50ml syringe is used with the apparatus, and a 100ml dose is desired in the medicament bag, the process described may be repeated twice. Likewise, two 50ml syringes could be each filled with a different medication (for instance, a biologic medication and normal saline) and each added to the bag in sequence.

Fig. 14 illustrates further steps of the use of the adapter 500 of the second embodiment of the present invention. Fig. 14 shows the stoppering and the removal of the adapter 500 from the drug container. When all drug components are in the drug container 300, the push rod 540 of the adapter 500 is pressed. First, the closure element 530 acts as a plunger and pushes all drug elements remaining in the cavity 520 into the drug container 300. The user may push with the thumb on the push rod 540 and concurrently holds the two wings 560 with index finger and middle finger to apply a force on the push rod 540 (see left-hand figure). At the end position (center figure) the closure element 530 is connected to the port, it for example snaps in, and seals and closes the drug container 300. By further pressing the push rod 540 of the adapter (right-hand figure) until the push rod 540 contacts the housing 510, the connection between the closure element 530 and the adapter 500 releases and the adapter 500 can be removed from the drug container 300 and discarded. The closure element 530 is now arranged on the drug container 300. The right-hand figure shows that the adapter housing 510 is already lifted a certain distance from the drug container 300.

Figs. 15 to 17 show the container 300 according to an aspect of the present invention in more detail. The container 300 is adapted to accommodate the medicament bag 310. In the illustrated embodiment, the medicament bag 310 is flexible. The medicament bag 310 has an inner space to accommodate a volume of liquid. The container 300 comprises a container housing 320 for accommodating the flexible bag 310, and in the illustrated embodiment supporting the medicament bag 310. The container 300 also has an entry port (or outlet port, respectively) 343 for accommodating or receiving the port 330 of the medicament bag 310 for communication of the inner space of the medicament bag 310 with the exterior of the container 300. The inlet port 343 is formed as a through hole. The container 300 has a container housing case or container frame 322 and a container housing lid 321. When the lid 321 is connected to the case or frame 322, the inner space for the medicament bag 310 is provided. However, the lid 321 is a preferred element, the container 300 could accommodate the flexible bag 310 without being closed by lid 321. The container housing lid 321 and the container housing case 322 each have a perimeter wall 323, 324. The perimeter walls 323, 324 provide rigidity to the container housing 320.

The container 300 also has one or more container connecting elements 340. The connecting elements 340 are adapted to mate with corresponding connecting elements of a flexible bag filling adapter, such as the adapter 100,500 of the present disclosure. In the illustrated embodiment two connecting elements 340 are provided. These are preferably arranged one on each side of the inlet port 343.

Preferably, each container connecting element 340 comprises a locking feature 341. More preferably, the one or more container locking features 341 comprise a case locking feature 3411 and a lid locking feature 3412. In other words, when the container 300 has a lid and the container300 is coupled to an adapter 100, 500, the adapter 100, 500 is coupled or connected to the container housing case 322 and the container housing lid 321. This allows for a coupling direction along the axis of the port 343. For example, the locking features 3411 and 3412 on the lid and on the case provide for a snap-on connection of the adapter on the container 300. Alternatively, the locking feature is provided only in the container housing case 322 and not in the container housing lid 321. With such a configuration the adapter 100, 500 can be coupled to the container 300 for example in a sliding movement perpendicular to the axis of the port 343.

In the preferred embodiment shown in Figs. 15 to 17, the container connecting element 340 is formed as a recess in the circumferential walls 323, 324 of the container housing case 322 and the container housing lid 321. The respective locking feature 341 is preferably formed as a ridge or ledge at the wall of the recess. The ridge or ledge can mate with a corresponding ledge on the adapter connecting element to releasably couple the two components together.

The adapter 100, 500, adapter housing 110, 510, and push rod 140, 540 may be constructed of one or more rigid plastic materials, such as polypropylene, polycarbonate, acrylonitrile butadiene styrene, polyamide, polystyrene, or combinations thereof. In some embodiments, portions of adapter housing 110, 510, and push rod 140, 540 may be over-molded on the side closest to the container 300 body with a soft, compliant material, such as thermoplastic elastomer or thermoplastic polyurethane, to improve comfort for a user of the device during filling of the container 300 or placement of the closure element 130,530.

The devices described herein can be used forthe treatment and/or prophylaxis of one or more of many different types of disorders.

Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (G I P) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1/PD-L1) inhibitors/modulators, B- lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAGS; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation wl37 (CDwl37) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR- related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrestspecific protein 6 (GAS6)/AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation wl23 (CDwl23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab- pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90- Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

Exemplary drugs that could be included in the delivery devices described herein include "generic" or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the "innovator" or "branded" version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz. Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.

Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOXG, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MIN E, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CH P, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

Various modifications to the embodiments described are possible and will occur to those skilled in the art without departingfrom the invention which is defined by the following claims.

The invention is further defined by the following clauses.

1. Adapter (100, 500) for filling and subsequent closing of a pharmaceutical composition container (300), the adapter (100, 500) comprising: a housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) coupleable to a port of the container (300); a closure element (130, 530) arranged in the cavity (120, 520) and displaceable from a first position to a second position, in a direction along the first axis (A); a push rod (140, 540) being arranged at least partially outside the cavity (120, 520) and being movable by a user in a direction along the first axis (A) for displacing the closure element (130, 530); the housing (110, 510) having an entry port (150, 550) with an entry port opening (151, 551) in communication with the cavity (120, 520), at least part of the entry port opening (151, 551) being located axially between the first position of the closure element (130, 530) and the cavity opening (121, 521) when viewed along the first axis (A).

2. The adapter (100, 500) of clause 1, wherein the entry port (150, 550) has an entry port channel (152, 552), at least part of the length of which is perpendicular to or is inclined with respect to the first axis (A). 3. The adapter (100, 500) of clause 1 or 2, wherein the adaptor (100, 500) has two opposing sides along the first axis (A), one side being the side where the adapter (100, 500) is connectable to a port (330) of the container (300), the other, second side for being held and/or operated by a user.

4. The adapter (100, 500) of any one of the preceding clauses, wherein the push rod (140, 540) has a generally T-shape in cross-section along the first axis (A).

5. The adapter (100, 500) of any one of the preceding clauses, wherein the adapter (100, 500) further comprises a pierceable septum (555) in the entry port channel (152, 552).

6. The adapter (100, 500) of any one of the preceding clauses, wherein the entry port (150, 550) comprises one or more of a self-sealing elastomeric septum, needleless connector, female Luer connection, male Luer connection, Luer access valve, Luer activated device, or combinations thereof, at the end opposite to the cavity opening (151, 551).

7. The adapter (100, 500) of any one of the preceding clauses, wherein the entry port (150, 550) is configured to cooperate with at least one or more of a male Luer connector, female Luer connector, vial adapter, vial spike, IV tubing set spike, or combinations thereof.

8. The adapter (100, 500) of any one of the preceding clauses, wherein the entry port (150, 550) is configured to cooperate with at least one closed-system transfer device or component.

9. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130, 530) is adapted to seal the port (330) of the container (300).

10. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130) is configured to remove substantially all of a drug from the cavity (120).

11. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130) is configured to remove substantially all of a drug from the cavity (120) after filling and displacement of the closure element (130, 530).

12. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130, 530) is adapted to enter into a connection with the port (330) of the container (300) and to be released from the adapter (100, 500) upon removal of the adapter (100, 500) from the container (300). 13. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130) is a plunger for expelling fluid from the cavity (120).

14. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130, 530) is a substantially elastomeric material.

15. The adapter (100, 500) of any one of the preceding clauses, wherein the closure element (130, 530) is a blend of thermoplastic elastomer and an olefin polymer.

16. The adapter (100, 500) of any one of the preceding clauses, wherein the cavity (120, 520) is made from an olefin polymer.

17. The adapter (100, 500) of any one of the preceding clauses, wherein the adapter (100, 500) is configured such that one or more portions of the adapter (100, 500) or the housing (110, 510) are removed from the container (300) after filling.

18. The adapter (100, 500) of any one of the preceding clauses, wherein the adapter (100, 500) is configured such that one or more portions of the adapter (100, 500) or the housing (110, 510) are removed from the container (300) after filling and displacement of the closure element (130, 530).

19. The adapter (500) of any one of the preceding clauses, wherein the adapter housing (510) has a protruding structure (560) for being gripped by a user during use.

20. The adapter (500) of clause 19, wherein the adapter housing (510) is generally elongate along the direction of the first axis (A), preferably generally cylindrical.

21. The adapter (500) of clause 19 or 20, wherein the push rod (540) protrudes along the first axis (A) from the adapter housing (510) at the side for being held and/or operated by a user.

22. The adapter (100) of any one of clauses 1 to 18, wherein the push rod (140) protrudes along the first axis (A) from the adapter housing (110) at the side for being held and/or operated by a user.

23. The adapter (100) of clause 22, wherein the adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) with the container housing (320).

24. The adapter (100) of clause 23, wherein the one or more connecting elements (160) provide a releasable connection between the adapter housing (110) with the container housing (320). 25. The adapter (100) of clause 24, wherein the releasable connection is a snap connection or a screw connection.

26. The adapter (100) of clause 23, 24, or 25, wherein the adapter housing (110) has a second axis (B) perpendicular to the first axis (A), and wherein the adapter housing (110) has two opposite connecting elements (160) for connecting the adapter housing (100) with the container housing (320), opposite along the second axis (B).

27. The adapter (100) of clause 26, wherein the connecting elements (160) are flexible elements providing a releasable connection to the container housing (320).

28. The adapter (100) of clause 27, wherein each flexible element is at its one end integral with the adapter housing (110) and the opposite flexible end comprising a locking feature (161).

29. The adapter (100) of clause 28, wherein the locking feature (161) is a ledge extending in a direction perpendicular to the plane defined by first axis (A) and second axis (B) and projecting along second axis (B), or the locking feature is a groove extending in a direction perpendicular to the plane defined by first axis (A) and the second axis (B) and being recessed along second axis (B).

30. The adapter (100) of any one of clauses 13 to 29, wherein the push rod (140) is embedded in the adapter housing (110) such that the outermost end surface (141) is flush with a surface (111) of the adapter housing (110).

31. The adapter (100) of clause 30, wherein the adapter housing (110) has a stepped structure so that the push rod (140) is displaceable towards the container (300).

32. The adapter (100) of clause 31, wherein the stepped structure is generally a U-shaped structure.

33. The adapter (100) of clause any one of the preceding clauses, wherein the entry port (150) comprises a valve element (170) for connecting the entry port (150) with a syringe (400).

34. The adapter (100) of clause 33, wherein the syringe (400) is a needleless syringe.

35. Container (300) for a pharmaceutical composition having a separable and removable adapter (100, 500) for filling and subsequent closing of the container (300), the adapter (100, 500) as defined in any one of the preceding clauses, the container (300) further comprising: a medicament bag (310), and a port (330) configured for being removably connected with the adapter (100).

36. Container (300) according to clause 35, wherein the medicament bag (310) is a flexible medicament bag, preferably a flat flexible bag.

37. Container (300) according to clause 36, wherein the container (300) further comprises a container housing (320) accommodating the medicament bag (310).

38. Container (300) according to clause 37, wherein the port (330) is part of the medicament bag (310) or part of the container housing (320).

39. Container (300) according to clause 37 or 38, wherein the container housing (320) comprises one or more container connecting elements (340) mating with the adapter connecting elements (160).

40. Container (300) according to clause 39, wherein each container connecting element (340) comprises a locking feature (341).

41. Container (300) according to clause 40, wherein the locking feature (341) is a corresponding groove or ledge.

42. Container (300) for a flexible bag (310) having an inner space to accommodate a volume of liquid, the container (300) comprising: a container housing (320) for accommodating the flexible bag (310); an outlet port (343) for communication of the inner space of the flexible bag (310) with the exterior of the container (300); and one or more container connecting elements (340) mating with connecting elements (160) of a flexible bag filling adapter (100).

43. Container (300) according to clause 42, wherein each container connecting element (340) comprises a locking feature (341).

44. Container (300) according to clause 42 or 43, wherein the container housing (300) has a container housing case (322) and a container housing lid (321).

45. Container (300) according to clause 44, wherein the one or more container locking feature (341) comprise a case locking feature (3411) and a lid locking feature (3412).

46. Container (300) according to any one of clauses 42 to 45, wherein the container connecting element (340) is formed as a recess in the circumferential walls (323, 324) of the container housing case (322) and the container housing lid (321). 47. Container (300) according to clause 46, wherein the locking feature (341) is formed as a ridge at the wall of the recess.

48. Container (300) according to any one of clauses 42 to 47, further comprising an adapter (100, 500) for filling and subsequent closing of the flexible bag (310) in the container (300).

49. Container according to clause 48, wherein the adapter (100, 500) comprises: a housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) coupleable to a port of the container (300); a closure element (130, 530) arranged in the cavity (120, 520); a push rod (140, 540) being arranged at least partially outside the cavity (120, 520) and being movable by a user; the housing (110, 510) having an entry port (150, 550) with an entry port opening (151, 551) in communication with the cavity (120, 520).

50. Combination of an adapter (100, 500) for filling and subsequent closing of a pharmaceutical composition container (300) and a container frame (322), the adapter (100, 500) comprising: a housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521); a closure element (130, 530) arranged in the cavity (120, 520) and displaceable from a first position to a second position, in a direction along the first axis (A); a push rod (140, 540) being arranged at least partially outside the cavity (120, 520) and being movable by a user in a direction along the first axis (A) for displacing the closure element (130, 530); the housing (110, 510) having an entry port (150, 550) with an entry port opening (151, 551) in communication with the cavity (120, 520), at least part of the entry port opening (151, 551) being located axially between the first position of the closure element (130, 530) and the cavity opening (121, 521) when viewed along the first axis; wherein the adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) with the container frame (322).

51. The adapter (100) of clause 50, wherein the one or more connecting elements (160) provide a releasable connection between the adapter housing (110) with the container frame (322). 52. The adapter (100) of clause 51, wherein the releasable connection is a snap connection or a screw connection.

Claims

1. Adapter (100, 500) for filling and subsequent closing of a pharmaceutical composition container (300), the adapter (100, 500) comprising: a housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) coupleable to a port of the container (300); a closure element (130, 530) arranged in the cavity (120, 520) and displaceable from a first position to a second position, in a direction along the first axis (A); a push rod (140, 540) being arranged at least partially outside the cavity (120, 520) and being movable by a user in a direction a long the first axis (A) for displacing the closure element (130, 530); the housing (110, 510) having an entry port (150, 550) with an entry port opening (151, 551) in communication with the cavity (120, 520), at least part of the entry port opening (151, 551) being located axially between the first position of the closure element (130, 530) and the cavity opening (121, 521) when viewed along the first axis (A).

2. The adapter (100, 500) of claim 1, wherein the entry port (150, 550) has an entry port channel (152, 552), at least part of the length of which is perpendicular to or is inclined with respect to the first axis (A).

3. The adapter (100, 500) of claim 1 or 2, wherein the adaptor (100, 500) has two opposing sides along the first axis (A), one side being the side where the adapter (100, 500) is connectable to a port (330) of the container (300), the other, second side for being held and/or operated by a user.

4. The adapter (100, 500) of any one of the preceding claims, wherein the closure element (130, 530) is adapted to seal the port (330) of the container (300).

5. The adapter (100, 500) of any one of the preceding claims, wherein the closure element (130, 530) is adapted to enter into a connection with the port (330) of the container (300) and to be released from the adapter (100, 500) upon removal of the adapter (100, 500) from the container (300).

6. The adapter (100, 500) of any one of the preceding claims, wherein the closure element (130) is a plunger for expelling fluid from the cavity (120).

7. The adapter (500) of any one of the preceding claims, wherein the adapter housing (510) has a protruding structure (560) for being gripped by a user during use.

8. The adapter (100) of any one of claims 1 to 6, wherein the push rod (140) protrudes along the first axis (A) from the adapter housing (110) at the side for being held and/or operated by a user.

9. The adapter (100) of claim 8, wherein the adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) with the container housing (320).

10. The adapter (100) of any one of claims 13 to 20, wherein the push rod (140) is embedded in the adapter housing (110) such that the outermost end surface (141) is flush with a surface (111) of the adapter housing (110).

11. Container (300) for a pharmaceutical composition having a separable and removable adapter (100, 500) for filling and subsequent closing of the container (300), the adapter (100, 500) as defined in any one of the preceding claims, the container (300) further comprising: a medicament bag (310), and a port (330) configured for being removably connected with the adapter (100).

12. Container (300) for a flexible bag (310) having an inner space to accommodate a volume of liquid, the container (300) comprising: a container housing (320) for accommodating the flexible bag (310); an outlet port (343) for communication of the inner space of the flexible bag (310) with the exterior of the container (300); and one or more container connecting elements (340) mating with connecting elements

13. Container (300) according to claim 12, further comprising an adapter (100, 500) for filling and subsequent closing of the flexible bag (310) in the container (300).

14. Container according to claim 13, wherein the adapter (100, 500) comprises: a housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) coupleable to a port of the container (300); a closure element (130, 530) arranged in the cavity (120, 520); a push rod (140, 540) being arranged at least partially outside the cavity (120, 520) and being movable by a user; the housing (110, 510) having an entry port (150, 550) with an entry port opening (151, 551) in communication with the cavity (120, 520).

15. Combination of an adapter (100, 500) for filling and subsequent closing of a pharmaceutical composition container (300) and a container frame (322), the adapter (100, 500) comprising: a housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521); a closure element (130, 530) arranged in the cavity (120, 520) and displaceable from a first position to a second position, in a direction along the first axis (A); a push rod (140, 540) being arranged at least partially outside the cavity (120, 520) and being movable by a user in a direction a long the first axis (A) for displacing the closure element (130, 530); the housing (110, 510) having an entry port (150, 550) with an entry port opening (151, 551) in communication with the cavity (120, 520), at least part of the entry port opening (151, 551) being located axially between the first position of the closure element (130, 530) and the cavity opening (121, 521) when viewed along the first axis; wherein the adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) with the container frame (322).